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• W2009589027 abstract "Randomized controlled trials (RCTs) are rightly considered to provide the highest quality, first-level information in evidence-based medicine, because their inherent design limits bias and confounding. However, a number of aspects of their design and conduct mean that they do not always accurately reflect actual clinical practice [1]: these include highly selected patient populations, treatment in specialist centers, and intensive clinical supervision and follow-up. Observational studies include a wide range of study designs (cohort, case control, and cross-sectional), the common feature of which is that they are non-interventional, although the participants are often selected on the basis of having previously had a specific intervention in the course of routine clinical practice. Such observational studies may include prospective data ascertainment, and are often used to assess the performance of therapies in the post-licensing period. Here, ‘noninterventional’ means that people are only enrolled into the study once they have been started on a particular therapy. Because observational trials are not randomized, they are susceptible to bias and confounding, and, while likely biases can be compensated for in the design and/or the statistical analysis, unknown factors may also influence results [2]. Another limiting factor is that many prospective observational trials lack a control population. With these reservations, data from observational trials can complement those from RCTs by providing an insight into how treatments perform in dayto-day practice in more clinically representative patient populations. Because of cost and resource advantages they are also applicable to larger and more diverse populations. The first article in this supplement will examine the different types of observational trials, how they differ from RCTs, and the relevance of the information they provide. Additionally, the roles of healthcare professionals, health authorities, and industry in the planning and conduct of such studies will be examined [3]." @default.
• W2009589027 created "2016-06-24" @default.
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• W2009589027 date "2010-05-01" @default.
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• W2009589027 title "How can observational trials inform and improve clinical practice?" @default.
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• W2009589027 doi "https://doi.org/10.1016/s0168-8227(10)00192-0" @default.
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